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FDA 510(k)

Frozen C

K号: K182392 · 2018-10-30

申请人B.M. Tech. Worldwide Co., Ltd.
决定日期2018-10-30
产品代码GEH
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Frozen C is the device name listed in this FDA 510(k) record. The listed applicant is B.M. Tech. Worldwide Co., Ltd.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182392. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Frozen C?

Frozen C is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is B.M. Tech. Worldwide Co., Ltd.. The 510(k) number is K182392.

When did Frozen C receive FDA 510(k) clearance?

Frozen C received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182392.

Who is the listed applicant for Frozen C?

The FDA 510(k) record lists B.M. Tech. Worldwide Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Frozen C?

The FDA product code for Frozen C is GEH.

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关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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